LYMPHIR
Approved · Active Modality: fusion protein
Aliases denileukin diftitox, E7777
Target IL-2 receptor
Partnerships Integris Pharma S.A.: exclusive distribution agreement (October 7, 2025) to make LYMPHIR available via Named Patient Programs in Greece, Cyprus, Malta, Bulgaria, Romania, Croatia, Serbia, Albania, Bosnia Herzegovina, Kosovo, Montenegro and North Macedonia
Indications- Relapsed or refractory cutaneous T-cell lymphoma (CTCL) (Approved)
- Immuno-oncology (solid tumors, CAR-T conditioning) (Phase 1)
Status note Recombinant DNA-derived fusion protein (IL-2-diphtheria toxin). FDA approved August 8, 2024 for relapsed/refractory CTCL (improved formulation of prior ONTAK, commercial sales of ONTAK discontinued in 2014); launched December 2025. Two investigator-initiated Phase 1 immuno-oncology trials completed: LYMPHIR prior to commercial CD19-directed CAR-T (topline reported March 4, 2026) and LYMPHIR + PD-1 inhibitor in recurrent/metastatic solid tumors (NCT05200559, University of Pittsburgh; topline reported March 10, 2026).
Per-asset detail extracted from the 10-Q filed 2026-08-14. Fields the filing does not state are marked "not disclosed" rather than filled from other sources.